Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction)

NCT04231578 | Completed

• 2 other identifiers: CIHR-IRSC:0525007697W7714-207266
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

Posttraumatic stress disorder (PTSD) is a common and disabling condition associated with intimate relationship problems and mental health problems in partners of those with PTSD. Recognizing the need to improve access to evidence-based interventions for those with PTSD and their families, our team has developed an Internet-delivered, self-help intervention to improve PTSD, enhance relationships, and improve partners' mental health: Couple HOPES (Helping Overcome PTSD and Enhance Satisfaction). Couple HOPES presents text and video-based content across seven self-help intervention modules, with modest support from paraprofessional coaches. Although the Couple HOPES platform has been developed, it remains uncertain whether Couple HOPES is feasible, usable, and efficacious in reducing PTSD and enhancing intimate relationship functioning. The proposed project aims to refine and finalize Couple HOPES with couples that include a veteran, service member or first responder with significant PTSD symptoms. This project includes initial testing of the intervention's preliminary efficacy, safety, and feasibility in a series of 10 couples (Phase 1), then in an uncontrolled trial of 20 couples (Phase 2), and then a randomized clinical trial comparing its efficacy to a delayed intervention control condition in 70 couples. Potential benefits of this study include couples learning new skills to reduce PTSD symptoms and enhance relationship functioning, although this is not guaranteed. Risks include participants finding the assessments distressing, or possible worsening of PTSD symptoms or relationship functioning. These risks will be mitigated by continuous monitoring of PTSD symptoms, relationship functioning, and adverse events, and intervention by study staff.

Conditions

Posttraumatic Stress Disorder

Keywords

Self-help; Internet-delivered intervention

Outcome Measures

Primary Outcomes (2)

• PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5 (PCL-5) with change measured as mean change from baseline

  Scores on the PCL-5 range from 0 to 80, with 80 being the most severe PTSD symptoms.

  Baseline, week 3, week 8, approximately once a week during treatment (for up to 8 weeks), after 3 modules are completed or 3 weeks into treatment, after 7 modules are completed or 8 weeks into treatment, 3 month post-treatment follow-up

• Couple Satisfaction Index (CSI-4) with change measured as mean change from baseline

  Score on the CSI-4 range from 0 to 21, with 21 being the most satisfied.

  Baseline, week 3, week 8, approximately once a week during treatment (for up to 8 weeks), after 3 modules are completed or 3 weeks into treatment, after 7 modules are completed or 8 weeks into treatment, 3 month post-treatment follow-up

Secondary Outcomes (1)

• Mean change from baseline on Ineffective Arguing Inventory

  Baseline, week 3, week 8, after 3 modules are completed or 3 weeks into treatment, after 7 modules are completed or 8 weeks into treatment, 3 month post-treatment follow-up

Other Outcomes (12)

• Significant Others' Responses to Trauma Scale with change measured as mean change from baseline

  Baseline, week 3, week 8, after 3 modules are completed or 3 weeks into treatment, after 7 modules are completed or 8 weeks into treatment, 3 month post-treatment follow-up

• Mean change from baseline on depression as measured by the Patient Health Questionnaire

  Baseline, week 3, week 8, after 3 modules are completed or 3 weeks into treatment, after 7 modules are completed or 8 weeks into treatment, 3 month post-treatment follow-up

• Mean change from baseline on alcohol use as measured by the Alcohol Use Disorders Identification Test: Self-Report Version

  Baseline, week 3, week 8, after 3 modules are completed or 3 weeks into treatment, after 7 modules are completed or 8 weeks into treatment, 3 month post-treatment follow-up

Study Arms (2)

Immediate Couple HOPES

EXPERIMENTAL

Immediately assigned to receive seven modules of an Internet-delivered self-help intervention with paraprofessional coaching for PTSD completed at the participant's own pace within 8 weeks.

Behavioral: Couple HOPES Guided, Internet-Delivered, Self-Help Intervention

Delayed Intervention

NO INTERVENTION

Participants will not receive Couple HOPES for the first 8 weeks, and complete assessments at the beginning, middle, and end of this period. After this 8-week delay, participants will then receive seven modules of an Internet-delivered self-help intervention with paraprofessional coaching for PTSD completed at the participant's own pace within 8 weeks.

Interventions

Couple HOPES Guided, Internet-Delivered, Self-Help Intervention BEHAVIORAL

Couple HOPES is a guided self-help intervention for individuals with PTSD and their partners based on Cognitive-Behavioral Conjoint Therapy for PTSD (Monson \& Fredman, 2012). This intervention consists of text and video-based content across seven intervention modules and phone and online-based coaching sessions with a paraprofessional. Participants are able to complete these modules in their own home or private location of their choosing. The primary outcomes are PTSD symptoms, relationship satisfaction, and the mental health and wellbeing of partners of those with PTSD.

Immediate Couple HOPES

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual who is a Canadian military member, veteran, or first responder with clinically significant levels of PTSD symptoms
• Must be willing to be audio-recorded for coaching sessions
• Intimate partner willing to participant and complete intervention modules together
• Access to high speed internet

You may not qualify if:

• Elevated suicide risk
• Severe physical aggression between partners in the past year
• Clinically significant PTSD symptoms in both members of the dyad

Sponsors & Collaborators

• Toronto Metropolitan University: lead

Study Sites (1)

Candice M. Monson

Toronto, Ontario, M5B 1Y3, Canada

Location

Related Publications (4)

• Monson, C. M., & Fredman, S. J. (2012). Cognitive-behavioral conjoint therapy for PTSD: Harnessing the healing power of relationships. New York, NY: Guilford.

  BACKGROUND

• Fitzpatrick S, Crenshaw AO, Valela R, Samonas C, Earle EA, Goss S, Hernandez KM, Bushe J, Varma S, Proctor D, Wagner AC, Goenka K, Luxor O, Collins A, Morland L, Shields N, Roth M, Doss BD, Schumm J, Monson CM. A randomized controlled trial testing couple HOPES: An online, self-help couples' intervention for posttraumatic stress disorder. J Consult Clin Psychol. 2025 Aug;93(8):580-594. doi: 10.1037/ccp0000965.

  PMID: 40811121 DERIVED

• Crenshaw AO, Whitfield KM, Collins A, Valela R, Varma S, Landy MSH, Ip J, Donkin V, Earle E, Siegel A, Samonas C, Bushe J, Mensah DH, Xiang A, Doss BD, Morland L, Wagner AC, Fitzpatrick S, Monson CM. Partner outcomes from an uncontrolled trial of Couple HOPES: A guided online couple intervention for posttraumatic stress disorder and relationship enhancement. J Trauma Stress. 2023 Feb;36(1):230-238. doi: 10.1002/jts.22878. Epub 2022 Sep 18.

  PMID: 36116104 DERIVED

• Monson CM, Wagner AC, Crenshaw AO, Whitfield KM, Newnham CM, Valela R, Varma S, Di Bartolomeo AA, Fulham L, Collins A, Donkin V, Mensah DH, Landy MSH, Samonas C, Morland L, Doss BD, Fitzpatrick S. An uncontrolled trial of couple HOPES: A guided online couple intervention for PTSD and relationship enhancement. J Fam Psychol. 2022 Sep;36(6):1036-1042. doi: 10.1037/fam0000976. Epub 2022 Mar 10.

  PMID: 35266773 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Candice M Monson, PhD

  Toronto Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participating couples are either non-randomized in early phases of project or randomized to either immediately receive the Internet-delivered Couple HOPES intervention or to a delayed intervention group, where they receive access to Couple HOPES 8 weeks later.

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: January 18, 2020
• Study Start: March 31, 2020
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2023
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)